Apparatus for delivering a device to a hollow organ

ABSTRACT

An apparatus for delivery of a device into a hollow organ and a method of delivery are provided. The apparatus includes an elongated tube having proximal and distal openings and being configured for carrying the device on a distal portion thereof. The apparatus further includes a tubular cover for covering at least a portion of the device when mounted on the elongated tube, the tubular cover being radially elastic and axially non-elastic. The tubular cover is retrievable into the elongated tube through the distal opening, such that when the device is mounted on the elongated tube and covered by the tubular cover, retrieval of the tubular cover into the elongated tube uncovers the device for delivery into the hollow organ.

FIELD AND BACKGROUND OF THE INVENTION

The resent invention relates to an apparatus for delivering a deviceinto a hollow organ. Embodiments of the present invention relate to anapparatus for delivering and deploying an intra-luminal sheath forbypassing an anastomosis site in a colon.

Surgical intervention can require an operative union of resected tissuesor a bypass of non-resected diseased tissue. Such union procedures,which are termed anastomosis, can be performed via open or minimalinvasive surgery where the ligated ends are manually sutured or stapledusing a surgical stapler. While an anastomosis may be end-to-end, itcould also be performed side-to-side or end-to-side depending on therequired reconstruction or bypass. Anastomosis can be performed onvascular structures, the gastrointestinal (GI) tract (includingesophagus, stomach, small bowel, large bowel, bile ducts, and pancreas),and the urinary tract (including ureters, urinary bladder and urethra).

Surgical anastomosis is a common procedure, in particular in thegastrointestinal (GI) tract. Virtually all elective resections ofgastrointestinal organs are followed by anastomoses to restorecontinuity.

Although commonly performed, GI anastomosis carry a relatively high riskof anastomotic leaks especially in subjects that are immuno-compromised,such as subjects undergoing chemotherapy. Such leaks must be identifiedin a reasonable amount of time to allow for medical intervention.

In order to address the problem of anastomotic leaks, several internalsheaths which bypass the anastomotic site have been devised. Suchsheaths are typically delivered via dedicated catheters and anchoredabove(upstream) the anastomotic site thereby supporting the flow ofmaterial to circumvent or bypass the anastomosis site.

Delivery of such devices to the anastomosis site requires precisepositioning and deployment as well as effective anchoring withouttraumatizing the tissue.

While reducing the present invention to practice, the present inventorshave devised an apparatus which can be used to deliver an intra-luminalsheath to the anastomosis site without causing tissue trauma duringdelivery or anchoring.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided anapparatus for delivery of a device into a hollow organ comprising: (a)an elongated tube having proximal and distal openings and beingconfigured for carrying the device on a distal portion thereof; and (b)a tubular cover for covering at least a portion of the device whenmounted on the elongated tube, the tubular cover being radially elasticand axially non-elastic; the tubular cover being retrievable into theelongated tube through the distal opening, such that when the device ismounted on the elongated tube and covered by the tubular cover,retrieval of the tubular cover into the elongated tube uncovers thedevice for delivery into the hollow organ.

According to further features in preferred embodiments of the inventiondescribed below, the apparatus further comprises an additional elongatedtube positioned within the elongated tube and being attached to thetubular cover structure, wherein the tubular cover is retrievable intothe elongated tube by pulling the additional elongated tube against theelongated tube.

According to still further features in the described preferredembodiments the elongated tube includes a hollow nose cone forming thedistal opening.

According to still further features in the described preferredembodiments the tubular cover is fabricated from an elastic materialhaving non-elastic axial elements.

According to still further features in the described preferredembodiments the elastic material is an elastic polymer.

According to still further features in the described preferredembodiments a proximal end of each of the elongated tube and theadditional elongated tube is attached to a user-operable handle.

According to still further features in the described preferredembodiments the device is mounted on a distal portion of the elongatedtube.

According to still further features in the described preferredembodiments the apparatus further comprises a fluid conduit fordelivering friction-reducing composition to a distal portion of theelongated tube.

According to still further features in the described preferredembodiments the conduit is removably attached to the elongated tube.

According to still further features in the described preferredembodiments a distal opening of the fluid conduit is positioned suchthat the friction-reducing composition is delivered between the tubularcover and the device when the device is mounted on the elongated tube.

According to still further features in the described preferredembodiments the friction-reducing composition is an oil or a water-based lubricant.

According to another aspect of the present invention there is provided amethod of delivering a device into a hollow organ comprising: (a)delivering into the hollow organ an elongated tube having proximal anddistal openings, the elongated tube having the device mounted thereuponand being at least partially covered by a tubular cover being radiallyelastic and axially non-elastic; (b) retrieving the tubular cover intothe elongated tube through the distal opening thereby uncovering thedevice; and (c) pulling the elongated tube in a proximal direction tothereby deliver the device to the hollow organ.

According to still further features in the described preferredembodiments the tubular cover is attached to an additional elongatedtube positioned within the elongated tube and further wherein (b) iseffected by pulling the additional elongated tube against the elongatedtube.

According to still further features in the described preferredembodiments the tubular cover is fabricated from an elastic materialhaving non-elastic axial elements.

According to still further features in the described preferredembodiments the device is a tubular sleeve having at least one toroidalballoon and further wherein the toroidal balloon is inflated to anchorthe tubular sleeve in the hollow organ prior to, or following (c).

According to still further features in the described preferredembodiments the hollow organ is a colon and the tubular sleeve is atleast 200 mm in length.

According to still further features in the described preferredembodiments the hollow organ is a colon and further wherein (a) iseffected by delivering the tubular sleeve through the anal orifice.

According to still further features in the described preferredembodiments at least one toroidal balloon is inflated via an inflationconduit having an inflation port positioned outside the body.

According to still further features in the described preferredembodiments the method further comprising delivering a friction-reducingcomposition to a distal portion of the elongated tube prior to (b).

According to still further features in the described preferredembodiments the delivering is effected via a fluid conduit having adistal opening positioned at the distal portion of the elongated tube.

According to still further features in the described preferredembodiments a distal opening of the fluid conduit is positioned suchthat the friction-reducing composition is delivered between the tubularcover and the device.

According to still further features in the described preferredembodiments the friction-reducing is an oil or a water -based lubricant.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a delivery apparatus thatcan be used to deliver a device into a hollow organ.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIG. 1 illustrates the present delivery apparatus with an intraluminaldevice mounted thereupon and covered by a tubular cover.

FIG. 2a illustrates the delivery apparatus of FIG. 1 without theintraluminal device.

FIG. 2b illustrates the tubular cover with attached/integratedlongitudinal struts.

FIG. 3 illustrates the delivery apparatus of FIG. 1 with theintraluminal device mounted thereupon and the tubular cover partiallywithdrawn into the lumen of the delivery apparatus through the distalopening of the elongated (outer) tube.

FIG. 4 illustrates the delivery apparatus of FIG. 1 with the tubularcover drawn into the lumen through the distal opening of the elongated(outer) tube.

FIG. 5 illustrates a fluid a conduit for delivering a friction-reducingcomposition to the distal portion of the delivery apparatus.

FIGS. 6a-h illustrate delivery and deployment of an intraluminal devicein a colon using the delivery apparatus of the present invention.

FIG. 7 illustrates a prototype of a delivery apparatus which includes alongitudinally elastic tubular cover. As is shown by this Figure,pulling of handle proximally stretches the tubular cover longitudinallyand prevents release of the device from the delivery apparatus.

FIG. 8 illustrates a prototype system including a delivery apparatus(A), a movement limiting band (B) and anastomosis shield device (C).

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of an apparatus which can be used to deliver adevice into a hollow organ. Specifically, the present invention can beused to deliver a device for bypassing an anastomosis site in a holloworgan such as a colon.

The principles and operation of the present invention may be betterunderstood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details set forth in the following description or exemplified bythe Examples. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein is for the purposeof description and should not be regarded as limiting.

Leaks from anastomosis sites are a major complication of surgical unionof hollow organ tissues. In fact, the rate and clinical implications ofanastomotic leakage in colorectal and colo-anal anastomosis oftentimesnecessitates a loop stoma for fecal diversion.

To address this problem, anastomosis protection devices for internallybypassing an anastomosis site have been developed. Such protectiondevices employ internally anchored sleeves (e.g. U.S. 20100010517, U.S.20100010518) or externally clamped sleeves (e.g. U.S. Pat. No.3,435,823, U.S. 20050033226) for routing feces and isolating it from theanastomosis site. Although bypass devices provide a promisingalternative to fecal diversion procedures, they have yet to meetclinical acceptance largely due to complications associated withsleeve-tissue anchoring and sleeve placement and removal.

U.S. Pat. No. 8,690,817 to the present inventors discloses a uniqueanastomosis bypass device that includes several expandable toroidalballoons. The balloons stabilize the device against the inner walls ofthe colon and provide sealing thereagainst, while an externally mountedband (surrounding the colon) limits movement of the intraluminal devicewithin the colon.

Experiments conducted by the present inventors have revealed thatdelivery of such an intraluminal device can be limited by less thanoptimal device unsheathing and deployment (see the Examples section formore detail).

In order to solve these problems and facilitate smooth delivery anddeployment of the intraluminal device, the present inventors havedevised a delivery apparatus which can be used to deliver and deploy anintraluminal device such as that described in US8690817.

Thus, according to one aspect there is provided an apparatus fordelivery of a device into a hollow organ.

As used herein, the phrase “hollow organ” refers to any hollow tissuestructure that serves as a conduit for biological material. Examplesinclude the GI tract, including the esophagus, stomach and intestines,the urinary tract, including the ureters, bladder and urethra, and thevascular system including arteries, veins and the like. As used herein,the phrase biological material includes, but is not limited to, feces,urine, blood and the like.

The delivery apparatus of the present invention includes an elongatedtube (also referred to herein as “outer tube”) having proximal anddistal openings; the outer tube is configured for carrying thedeliverable device thereupon. The delivery apparatus further includes atubular cover for covering at least a portion of the device when mountedon the outer tube. The tubular cover is retrievable into the outer tubethrough the distal opening, such that when the device is mounted on theouter tube and covered by the tubular cover, retrieval of the tubularcover into the outer tube uncovers the device for delivery into thehollow organ.

As is further described in the Examples section which follows,experiments conducted with various configurations of a tubular coverhave revealed that the friction between the deliverable device and thetubular cover disposed therearound prevents efficient uncovering of thedevice due to longitudinal stretching of the tubular cover in responseto a pulling force. Such stretching resulted in a reduction of thediameter of the tubular cover and an increase in friction between thecover and delivered device that prevented device release.

In order to overcome these problems, the tubular cover of the presentdelivery apparatus was designed with radial elasticity and axiallyrigidity (inelasticity).

The radial elasticity enables the tubular cover to closely hug and applycompressive (packing) forces on the deliverable device or a portionthereof, while the longitudinal (axial) rigidity (non-elasticity)prevents longitudinal stretching of the tubular cover when pulled intothe outer tube through the distal opening thereof.

The tubular cover is pulled into the outer tube by an additionalelongated tube (also referred to herein as “inner tube”) which isdisposed within the outer tube and is attached to the distal portion ofthe tubular cover. Pulling of the inner tube with respect to the outertube pulls the tubular cover in a distal direction into the distalopening of the outer tube thereby uncovering the distal portion of theouter tube (on which a deliverable device is mounted.

FIGS. 1-5 illustrate one embodiment of the present apparatus which isreferred to herein as apparatus 10.

Apparatus 10 includes an outer tube 12 that is disposed over an innertube 14 (not visible, indicated with dotted line). Outer tube 12 can befabricated from PTFE, Nylon, Pebax, or any other thermoplastic/elasticpolymer (with or without braid reinforcement), or a metal (e.g.stainless steel or Nitinol). Outer tube 12 can be thin (wall thicknessof 0.5-1 mm or less) or slotted to allow flexibility and yet providepushability. The outer diameter (OD) of outer tube 12 can be 3-7 mmwhile the inner diameter (ID) can be 2-6 mm. Outer tube can befabricated via extrusion or any other suitable fabrication approach.

Inner tube 14 can be fabricated via, for example, extrusion using thematerials described above. Inner tube 14 can have an OD of 2-6 mm and anID of 0.1-1 mm.

At least a distal portion 13 of outer tube 12 is configured for carryinga deliverable device. Device 15 shown in FIGS. 1, 3 and 5 is configuredfor bypassing/shielding colon anastomosis sites and is about 200-500 cmin length. As such, device 15 is disposed over the length of outer tube12, with only a tissue-anchoring segment thereof (having two toroidalanchoring balloons 19 shown in FIGS. 3 and 5) being covered by tubularcover 24. However, shorter devices can be mounted over distal portion 13and be completely covered by tubular cover 24.

Apparatus includes handle 16 having two portions, a proximal portion 20which is connected to inner tube 14 and a distal portion 18 which isconnected to outer tube 12. Handle portion 18 and 20 can be fabricatedvia machining, 3D printing or molding using a variety of polymers and/oralloys (e.g. POM-C, ABS, polycarbonate, stainless steel etc.) Handle 16can be 100-200 mm in length and 15-45 mm in diameter.

Proximal portion 20 can be pulled against distal portion 18 to therebypull inner tube 14 with respect to outer tube 12. Handle 16 includes asafety mechanism 26 (e.g. a removable pin, a movable element, a ratchetmechanism or the like) for preventing inadvertent pulling of portion 20with respect to portion 18 when apparatus 10 is used.

Distal end 22 of inner tube 14 is connected to a tubular cover 24 (FIG.2a ) which is configured for partially or fully covering a deliverabledevice (partial covering is shown with device 15 of FIG. 1). Pulling ofportion 20 with respect to portion 18 pulls distal end 22 of inner tube14 in a proximal direction and withdraws tubular cover 24 into outertube 12 through opening 26 (FIG. 3). Tubular cover 24 can be partiallyor completely pulled into outer tube 12 (partial withdrawal into outertube 12 shown in FIG. 3). A graduated scale 17 (FIGS. 3 and 4) disposedwithin handle 16 can become visible as portion 20 is pulled to indicatethe portion (in percent or mm) of tubular cover withdrawn into outertube 12.

Tubular cover 24 is a radially elastic, longitudinally rigid tubularstructure which is capable of elastically stretching radially toaccommodate device 15 and apply a compressive force thereupon.

Tubular cover 24 can be fabricated from nylon, silicone, latex, rubber,polyurethane or the like with a radial compliance of 10-100%.Fabrication can be effected using common approaches such as dipping,blow molding, casting, extrusion or the like.

The longitudinal rigidity of tubular cover 24 is provided bylongitudinal reinforcement, e.g. axial elements, such as struts 25 whichare attached to, or integrated into tubular cover 24 (FIG. 2b ). Struts25 can be embedded into tubular cover 24 during manufacturing (dipping,over molding) or joined thereto via gluing, sandwiching (dual layer) orthe like. Struts 25 can be attached to distal connector 29 of tubularcover 24 which is in turn connected to (glued/welded) inner tube 14.

Any number of struts 25 can be provided in or on tubular cover 24. Forexample, 4-8 struts spanning the length of tubular cover 26 can bearranged around the circumference thereof in symmetrical ornon-symmetrical spacing. Struts 25 can span the entire length of tubularcover 26 or a portion thereof (e.g. 70-95%).

Struts 25 can be configured to provide longitudinal rigidity only underpulling forces, since tubular cover 24 is pulled to uncover thedelivered device. As such, struts 25 can be fabricated as strings(single filament of braided), or ribbons from inelastic polymers such asnylon, PLA or PEEK, or from natural materials such as silk or cotton.Struts 25 can also be fabricated from rigid materials such as, alloys(stainless steel) and the like. The axial compliance of struts 25 isless than 20%, preferably less than 10%.

FIG. 4 illustrates apparatus 10 without device 15 and with tubular cover24 partially withdrawn into outer tube 12 showing distal portion 13 andnose cone 28. Nose cone 28 is shaped to facilitate delivery of apparatus10 into the hollow organ and to enable easy retraction thereof. Inaddition, nose cone 28 also facilitates collection of tubular sheath(which slides thereupon) into outer tube 12. Nose cone 28 is preferablyfabricated from low friction materials such as Teflon or Delrin. Nosecone 28 also functions as a distal stop to prevent any distal movementof the device carried on outer tube 12 during unsheathing of tubularcover 24.

FIG. 5 illustrates apparatus 10 with tubular cover 24 partially coveringdevice 15 mounted on outer tube 12 and a conduit 30 disposed betweenhandle 16 and distal portion 13. Conduit 30 includes a proximal opening32 and distal opening 34. Conduit 30 can be used to deliver a frictionreducing compound to distal portion preferably under tubular cover 24within a space between tubular cover 24 and device 15. Such a frictionreducing compound can be water or oil-based and can include glycerin andhydroxyethyl cellulose lubricants.

Delivery of the friction reducing compound can be facilitated by asyringe or pump connected to proximal opening 32 via, for example, aLuer lock mechanism. When delivered under tubular cover 24, the frictionreducing compound can decrease friction caused by contact of inner wallsof tubular cover 24 and outer walls of device 15 to thereby facilitateunsheathing of device 15 (via withdrawal of tubular cover 24 into outertube 12). Delivery of the friction reducing compound can be effectedprior to positioning of apparatus 10 carrying device 15 in the holloworgan, or following such positioning and prior to pulling of inner tube14 with respect to outer tube 12.

Apparatus 10 can be used to deliver any intraluminal device into anyhollow organ. One preferred device deliverable by apparatus 10 is theanastomosis bypass device described in U.S. Pat. No. 8,690,817 andgenerally shown in FIGS. 1, 3 and 5.

Such a device is a tubular sleeve constructed from silicone, PTFE,Dacron™ or latex or any other suitable material and having dimensions inthe range of 250-500 mm length, 25-50 diameter and 0.05-1 mm wallthickness.

As is further described herein under, the movement of the tubular sleevewithin the hollow organ (specifically downstream movement) is limitedvia an externally mounted movement-limiting element which is preferablyconfigured as a band loosely encircling the hollow organ.

The sleeve includes an upstream opening for receiving the biologicalmaterial transported through the hollow organ and downstream openingwhich serves as an exit point for the biological material.

The sleeve can include two distinct functional portions. A first(distal) portion functions in stabilizing the sleeve within the holloworgan and sealing it with respect to the hollow organ inner walls, thusserving as the entry portion for the biological material. The firstportion is preferably more rigid in nature and can be shaped tofacilitate movement of the biological material from the hollow organ andinto the sleeve. The first portion of the sleeve is preferablyconstructed from silicone (Shore A 30-80), with a thickness of 0.1-0.6mm and configured with an external diameter of 30-60 mm, and a length of25-100 mm. This portion can also include stabilizing struts andinflatable external balloons for anchoring and stabilization. Althoughthe diameter of the first portion can increase slightly under internalpressure exerted by passage of biological material, such increase istypically no more than 5-15% of the fully open diameter.

A second (proximal) portion of the sleeve can function in directing thebiological material moving through the sleeve into a portion of thehollow organ downstream of the anastomosis site and/or outside the body.As such, this portion of the sleeve is designed to contain thebiological material while providing some accommodation for volume andmovement. The second portion of the sleeve can be elastic and flimsy andis preferably constructed from a silicone material (Shore A value of5-40) and a thickness of 0.05-0.3 mm. Depending on the anastomosislocation along the colon the second portion of the sleeve can range inlength from 150-450 mm and 20-40 mm in diameter when fully open. Forexample, when utilized in bypassing a low colorectal anastomosis, thesecond portion of the sleeve can be 150-350 mm in length when fullydeployed.

The first portion is preferably contiguous with the second portion andis thus fabricated as one unitary structure or assembled from twoirreversibly attached portions (using for example, adhesives, mechanicalfasteners and the like) which are assembled prior to positioning.

The first portion can also include a mechanism for further stabilizingthe sleeve in the hollow organ and limiting its movement against theexternally mounted movement-limiting element.

Such a mechanism can include an expandable structure which can be usedfor increasing the external diameter of the first portion followingdeployment. Examples include, stent-like bands which are expandedfollowing deployment, compressed foam-like elements (disposed as a ringor discrete ‘blocks’ around the outer circumference of the firstportion).

Expansion of such mechanisms can be effected by releasing a constrainingmechanism such as a sheath or a pull-string. For example, a stent likeband (cut out of a Nitinol or stainless steel tube or braided fromNitinol or stainless steel wire) initially shaped to about 50 mm outerdiameter (OD) is compressed into a sheath with 10 mm internal diameter(ID); once released from the sheath, the stent-like band willelastically expand to the original 50 mm diameter.

A presently preferred expandable structure includes one or more (e.g. 2or 3) inflatable structures (balloons/bladders/sacs) disposed as a ring(e.g. toroidal balloons) or a plurality of discrete inflatablestructures around the outer circumference of the first portion.

Inflation of such an inflatable structure can be effected via aninflation conduit disposed within a sidewall of the sleeve. Depending onthe anastomosis bypassed, such conduit can run the length of the sleevefrom the distal opening to the inflatable structure(s), or it cantraverse only a portion of this length (e.g. 100-400 mm).

As is mentioned above, the system of the present invention also includesa movement-limiting element for limiting the movement of the sleeve andpreventing the first portion thereof from migrating past the anastomosissite (in a direction of flow through the hollow organ).

The presently preferred configuration of a movement-limiting element isa band encircling the outer surface of the hollow organ. It will beappreciated that such a band need not completely encircle the holloworgan; as such it can be an open band covering, for example, about 270degrees of the circumference of the hollow organ.

A presently preferred configuration of the band is configured such thatno substantial radial force is applied to the hollow organ when in use.Such a configuration negates the possibility of tissue ischemia andnecrosis especially when the hollow organ is, for example, a colon whichdistends when fecal matter passes there through.

A hollow organ such as a colon is designed to radially expand in orderto accommodate passage of feces during peristalsis (about 3-4 times perday). Such expansion can increase the diameter of a colon from 3 to 6cm. A band positioned in close contact with the outer wall of the coloncan apply inward pressure on the wall tissue when the colon expandsduring passage of feces. Such pressure can lead to tissue ischemia andnecrosis and or to tissue erosion dues to both compressive forces andaxial forces and frictional forces that result from axial movement ofthe colon with respect to the band.

To solve this problem, the band of the present invention can beconfigured to closely encircle the hollow organ and elastically expandwhen the organ expands, or alternatively and preferably the band can beconfigured with a diameter slightly smaller than that of the expandedorgan (e.g. about 15-30% smaller), but larger than that of the relaxedstate of the hollow organ (e.g. about 15-30% larger). In the case ofcolon anastomosis, the band can be fabricated with an internal diameterof 30 -50 mm and a substantially rigid (e.g. 10% compliance) internalcircumflex. Since the distal portion of the (internal) sleeve isrelatively rigid (as described above), it may limit organ radialexpansion at the site around and distally to the anastomosis and thusreduce contact forces/pressures between the organ outer wall and theband inner diameter.

The band limits movement of the sleeve (specifically the first portionof the sleeve) by functioning as a stop for the first portion of thesleeve (e.g. a stop for the balloon or balloon inflated around the firstportion of the sleeve).

For example, a band having an internal diameter of 40mm would functionas a movement stop for a sleeve which includes a first portion having anexternal diameter of 50 mm and yet such a band would not applycompressive forces to the outer colon wall.

In order to limit migration of the sleeve downstream past theanastomosis site, the band is preferably located at or above theanastomosis site. To prevent migration, the band is secured to thetissue at the desired site via anchors, adhesive, sutures and the like.Such securement can be to the outer wall of the hollow organ or totissues adjacent thereto. In the case of colorectal anastomosis, theband can be located about 50-100 mm above (upstream) the anastomosis andaxially secured in place by threading the band through the colonmesentery.

The band is delivered as a linear strip and closed to a circle aroundthe hollow organ using, for example, a latch, a suture, a lasso suturearound the band or other locking mechanisms. Delivery of the band ispreferably effected through an incision in the abdominal wall. Thediameter of the band can be adjustable prior to or following positioningusing, for example, a ratchet concept in which the relatively stiffouter rim of the band is tuned and locked to a diameter that will allowthe above defined gap between the colon and the internal “relativelysoft” inner band material or a Lasso concept in which the diameter ofthe ring is limited (and changed) by a “suture” going around the softinner ring material. In that concept shortening of the suture lengthwill decrees the ring OD.

According to another aspect of the present invention there is provided amethod of delivering a device into a hollow organ using apparatus 10.

Delivery of a device 15 into a hollow organ using apparatus 10 isexemplified by FIGS. 6a-h which illustrate delivery of an anastomosisbypass device into a colon.

Apparatus 10 with a mounted device is inserted through the anus andadvanced to the anastomosis site until the distal end is locatedproximal to the external ring (FIG. 6a ). A safety pin locking portion20 to portion 18 is removed and the handle is pulled proximallywithdrawing the tubular cover and exposing the device (FIGS. 6b-d ).Starting with the proximal balloon, each balloon of the device isinflated with 15 ml of saline using a standard 20 ml syringe positionedoutside the body (FIG. 6e ). Once the balloons are inflated, apparatus10 is completely withdrawn from the colon/rectum via gentle pulling(FIGS. 6f-g ) leaving the device anchored in position in the colon (FIG.6h ).

As used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting. Additionally, each of the various embodiments and aspects ofthe present invention as delineated hereinabove and as claimed in theclaims section below finds experimental support in the followingexamples.

EXAMPLES

Reference is now made to the following examples, which together with theabove descriptions, illustrate the invention in a non limiting fashion.

Example 1 Animal Testing

A delivery apparatus prototype constructed having an elastic tubularcover was evaluated in pigs.

Uncovering the delivered device by pulling the elastic cover into theelongated tube proved extremely difficult due to high frictional forcesbetween the tubular cover and device and colon. When the handle waspulled proximally, the tubular cover stretched longitudinally (axially)and remained in position (FIG. 7 illustrates a deployed deliveryapparatus outside the body, stretched cover indicated by arrow)preventing release of the device from the delivery apparatus.

To traverse this limitation of an axially elastic tubular cover, thepresent inventors fabricated an improved prototype having a tubularcover which is radially elastic and longitudinally inelastic. Thisimproved prototype was evaluated in 16 animal trials (pigs) and resultsshowed that the tubular cover was easily withdrawn into the elongatedouter tube of the apparatus to uncover the device and enable deliverythereof.

Example 2 Human Testing

A prototype of the present delivery device was tested in human subjects(FIG. 8). A single arm open label study was conducted in order toevaluate safety, tolerability and performance profile of the presentdelivery apparatus and the intraluminal device delivered thereby(described in U.S. Pat. No. 8,690,817) in patients undergoing colorectalsurgery.

The objectives of this study were to assess the performance of thedelivery apparatus and the device delivered thereby.

Methodology

A total of 14 subjects (7 males/7 females) were enrolled and completed30 days follow up to date. A single subject (female) was excluded fromthe study due to failure of leak test.

Subjects were scheduled for elective colorectal surgery as per the sitestandards. The device was deployed in the anastomosis site as follows.

Briefly, the external ring/band (B) was positioned around the colonupstream of the anastomosis site during the open part of the procedurewhen the resected bowel was pulled out of the abdominal wall through asmall incision. The delivery apparatus (A) with a mounted device (C) wasinserted through the anus and advanced to the anastomosis site until thedistal end of the delivery apparatus was located upstream of theexternal ring (B). The handle of the delivery apparatus was unlocked andpulled proximally to withdraw the tubular cover and expose the device.Starting with the proximal balloon, each balloon of the device wasinflated with saline using a standard 20 ml syringe positioned outsidethe body. Once the balloons were inflated, the delivery apparatus wascompletely withdrawn from the colon/rectum via gentle pulling leavingthe device anchored in position in the colon.

All variables concerning the procedure were collected including durationof the entire procedure, additional time for application of the device,inspection of the donuts, and whether a diverting stoma had beencreated.

In 13 patients (7 men, 6 women) a low colorectal resection wasperformed. The indication for treatment in all patients was colon andrectal cancer. The average age of the patients was 65 years (range,51-83 y). Subjects' BMI ranged from 20 to 32 with average of 27.9.Preoperative neo-adjuvant chemo radiotherapy had been given to 6patients.

Type of surgery was diverse and included 2 open surgeries, 9laparoscopic surgeries, 1 Robotic surgery converted to open and 1robotic converted to lap. In all cases, delivery of the device wasthrough the anal orifice.

The average duration of the surgical procedure was 231 minutes (range,125-332 min). Application and deployment of the device added a median of7 minutes to the procedure (range 5-21 min). The median distance fromthe anal verge to the anastomosis was 5 cm (range, 2-14).

In 6 of the procedures, a diverting stoma was created in addition to theplacement of the device. Device removal was performed per protocol onday 9-11 post procedure for 12 subjects. Early removal was performed inone patient on day 4 (subject 03-02) due to leakage from the anastomosissite.

Post-surgery activities included a daily evaluation of subject'sclinical state and assessments/record of temperature, passing flatus andbowel movements, concomitant medications (with focus on laxative,antibiotics, parenteral narcotics, or oral analgesic), food intaketolerability (liquid/solid) and catheter use.

On Day 10 (±1), a rectal contrast enema was done according toinstitution standard technique to determine device positioning andintegrity of the anastomosis, followed by device removal.

Approximately 30 (±5) days post-surgery, subjects returned to theclinic/hospital for a long-term follow-up safety evaluation of adverseevents, physical examination (digestive system) and concomitantmedications.

Results

Delivery was evaluated by the surgeon using feedback questionnaire.Answers were evaluated using a 5 point scale, with 1=must improve, and5=Excellent. Average scores are detailed in the Table below.

TABLE 1 Surgeon Feedback - Device Usability Average score Definition 1Learn-ability of the technique (compared 4.67 Intuitive/ to othersystems) Memorable 2 Overall level of complexity of the device 4.17Clear (general) 3 Device ease of use 4.17 Fairly easy 4 Compatibilityand adequacy of device design 4.08 Good to anatomy 5 Device externalring deployment 4.33 Good 6 Device internal sheath deployment 4.08 Good(including positioning & balloons inflation) 7 Withdrawal of thedelivery system after 4.25 Good deployment 8 Fixation of external ringconnecting tube 4.50 Excellent 9 Fixation of inflation tubes 4.33 Good10 Removal of external ring 4.42 Good 11 Removal of internal sheath 4.33Good

Overall device usability was found to be very good (average score 4.3).The physicians found it to be simple, clear and easy to use throughoutall stages of deployment and removal.

The application of the device can be performed easily by any surgeonexperienced in colorectal anastomoses procedures, with medianapplication time of 7 minutes (5-21) vs. stoma formation 15 minutes(10-30).

All subjects completed the study with no incidents of death or majorcomplications such as septic shock, general peritonitis etc. Patientsdid not report major discomfort caused by the sheath. A minimalincontinence for loose stool was observed as long as the sheath was insitu.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

1. An apparatus for delivery of a device into a hollow organ comprising:(a) an elongated tube having proximal and distal openings and beingconfigured for carrying the device on a distal portion thereof; and (b)a tubular cover for covering at least a portion of the device whenmounted on said elongated tube, said tubular cover being radiallyelastic and axially non-elastic; said tubular cover being retrievableinto said elongated tube through said distal opening, such that when thedevice is mounted on said elongated tube and covered by said tubularcover, retrieval of said tubular cover into said elongated tube uncoversthe device for delivery into the hollow organ.
 2. The apparatus of claim1, further comprising an additional elongated tube positioned withinsaid elongated tube and being attached to said tubular cover structure,wherein said tubular cover is retrievable into said elongated tube bypulling said additional elongated tube against said elongated tube. 3.The apparatus of claim 1, wherein said elongated tube includes a hollownose cone forming said distal opening.
 4. The apparatus of claim 2,wherein said tubular cover is fabricated from an elastic material havingnon-elastic axial elements.
 5. The apparatus of claim 2, wherein saidelastic material is an elastic polymer.
 6. The apparatus of claim 2,wherein a proximal end of each of said elongated tube and saidadditional elongated tube is attached to a user-operable handle.
 7. Theapparatus of claim 1, wherein the device is mounted on a distal portionof said elongated tube.
 8. The apparatus of claim 1, further comprisinga fluid conduit for delivering friction-reducing composition to a distalportion of said elongated tube.
 9. The apparatus of claim 8, whereinsaid conduit is removably attached to said elongated tube.
 10. Theapparatus of claim 8, wherein a distal opening of said fluid conduit ispositioned such that said friction-reducing composition is deliveredbetween said tubular cover and the device when the device is mounted onsaid elongated tube.
 11. (canceled)
 12. A method of delivering a deviceinto a hollow organ comprising: (a) delivering into the hollow organ anelongated tube having proximal and distal openings, said elongated tubehaving the device mounted thereupon and being at least partially coveredby a tubular cover being radially elastic and axially non-elastic; (b)retrieving said tubular cover into said elongated tube through saiddistal opening thereby uncovering said device; and (c) pulling saidelongated tube in a proximal direction to thereby deliver the device tothe hollow organ.
 13. The method of claim 12, wherein said tubular coveris attached to an additional elongated tube positioned within saidelongated tube and further wherein (b) is effected by pulling saidadditional elongated tube against said elongated tube.
 14. The method ofclaim 13, wherein said tubular cover is fabricated from an elasticmaterial having non-elastic axial elements.
 15. The method of claim 13,wherein the device is a tubular sleeve having at least one toroidalballoon and further wherein said toroidal balloon is inflated to anchorsaid tubular sleeve in the hollow organ prior to, or following (c). 16.The method of claim 15, wherein the hollow organ is a colon and saidtubular sleeve is at least 200 mm in length.
 17. The method of claim 15,wherein the hollow organ is a colon and further wherein (a) is effectedby delivering said tubular sleeve through said anal orifice.
 18. Themethod of claim 15, wherein said at least one toroidal balloon isinflated via an inflation conduit having an inflation port positionedoutside the body.
 19. The method of claim 13, further comprisingdelivering a friction-reducing composition to a distal portion of saidelongated tube prior to (b).
 20. The method of claim 19, wherein saiddelivering is effected via a fluid conduit having a distal openingpositioned at said distal portion of said elongated tube.
 21. The methodof claim 20, wherein a distal opening of said fluid conduit ispositioned such that said friction-reducing composition is deliveredbetween said tubular cover and the device.
 22. (canceled)